Status:
WITHDRAWN
ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice
Lead Sponsor:
Takeda
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to describe physician-reported clinical effectiveness outcomes, as determined by Harvey-Bradshaw Index (HBI) assessment, in biologic-naive participants with CD over 12 mon...
Detailed Description
This is a non-interventional, single-cohort, prospective study of participants with moderate to severe CD. The study will review medical charts with prospective patient-reported outcome measures to pr...
Eligibility Criteria
Inclusion
- Is enrolled in Takeda's participant support program prior to receiving vedolizumab.
- Has a diagnosis of moderately-to-severely active CD, as documented in the medical records.
- Scheduled for initial vedolizumab treatment per usual care recommendation.
- Was biologic-naive at time of initiating vedolizumab treatment.
Exclusion
- Was prescribed vedolizumab as part of a clinical study.
- Has isolated and active perianal disease in the absence of luminal CD.
Key Trial Info
Start Date :
September 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04349449
Start Date
September 30 2020
End Date
November 30 2022
Last Update
October 6 2020
Active Locations (14)
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1
Kelowna GI Associates
Kelowna, British Columbia, Canada, V1Y 6J6
2
Fraser Clinical Trials Inc.
New Westminster, British Columbia, Canada, V3L 3W4
3
The Winnipeg Clinic
Winnipeg, Manitoba, Canada, R3C 0N2
4
REGIONAL HEALTH AUTHORITY B doing business as HORIZON HEALTH NETWORK
Fredericton, New Brunswick, Canada, E3B 4R3